An Idea Factory for Pathology Informatics and the Clinical Laboratory. Presented by the Pathology Education Consortium (PEC).

15 posts from June 2012

As in a number of other product categories, Apple has "changed everything" with its deployment of Siri on the iPhone. The company didn't invent the technology but is going a long way toward popularizing it. I did not fully understand this until I read a recent article on the topic (see: Why Siri Matters). Below is an excerpt from it:

...[A] trend that bears on the future of computing went mostly unnoticed [at a recent computer show].The revolution in voice-controlled computing is advancing slowly and quietly, with Apple's Siri personal assistant leading the way. Apple didn't invent the idea or even the technology Siri is based on. It purchased Siri through an acquisition, polished the user experience and baked it into the iPhone 4S. The launch of that device last October kicked off a new era in computing: one in which people command data, content and services using their voices. Siri rolled out with deliberately scaled-back features and compatibility. Now we're beginning to see how Apple plans to expand it. Last week, the company announced Siri support for more languages and availability on the iPad, representing an expansion in terms of both geography and cross-device compatibility. These new features are incremental, but they represent important steps toward an era of voice-activated computing that's just around the corner.Last week's announcements suggest that Apple wants to establish a meaningful presence in automobiles, and Siri is at the middle of it all. By fall 2012, Siri will land not only in tablets (and presumably a second smartphone, the iPhone 5), but also in cars from Audi, BMW, Chrysler, GM, Honda, Jaguar, Land Rover and Toyota....Apple's success at getting voice control into the market for mobile devices sets it apart. Each quarter, the company sells an astonishing number of iOS devices, which now make up more than 75% of total revenue....The technology will find its way into Apple's desktop operating system, which continues to evolve into something more and more akin to iOS....Apple's strategy implies that voice control will become completely normal before long. If Apple succeeds in weaving Siri thoroughly enough into daily life to influence consumer demand for this type of functionality, its competitors will have little choice but to respond. Their voice-control technologies will evolve alongside Apple's, creating a virtuous cycle of competition and upgrades.

I agree with all of the points in this article. In my own case, I was aware that I had voice-controlled web search and texting on my Android cell phone. However, I was reluctant to put the technology to a test -- part laziness and part lack of confidence in it. However, seeing the Siri/iPad commercials on TV prompted me to give it a try. I have now installed a Siri "wannabe" on my cell phone called Skyvi. I have trained it to recognize the names of of all of my common contacts. I then merely launch the app and say: phone (or text) Jack Spratt. It also dictates to me all incoming texts that I have previously often ignored. Skyvi is not as sophisticated as Siri, I am sure, but I like the technology and it saves me time and effort.

Like other technology, voice control apps require some up-front learning to understand how to use them. One sometimes avoids this out of anxiety or lack of time or a belief that the effort won't be rewarded. On occasion, there is a downstream payoff for the upfront time and effort. Siri changes everything by giving us more confidence in the technology and, in the long run, we will be well served by it.

In a number of previous notes, I have made a case for having patients take ownership for their own health, particularly through preventive and predictive medicine. By this I have meant that they should improve their health through such measures as weight loss, exercise, less alcohol consumption, and smoking cessation. However, such "health ownership" can also entail observation and physiologic monitoring by individuals of their health status. A recent article addressed this topic (see: Patients becoming monitors of their own health). Below is an excerpt from it:

In the future, patients will become even more involved in the observation and monitoring of their own health or illnesses. For example, blood pressure can be checked 24 hours a day using a blood pressure cuff at home. “This is the classic example,” notes Professor Dr. Thomas Kubiak. “As time goes on, we will have to increasingly integrate new health observation and monitoring techniques into our daily lives. This will influence the situations of both patients and doctors.” [Dr. Kubiak and a health psychologist colleague] believe that our everyday state of health and behavior is much more helpful in determining proper diagnoses and therapies than lab-only results or questionnaires in which patients are asked to provide retrospective information about their state of health over the last few weeks or months. For chronic headaches, for example, it helps to keep a regular diary that tracks when headaches occur and what might have triggered them. There are also many ways for diabetes patients to check their own blood sugar levels and continually keep track of the results through devices that then help determine the proper insulin dosage....

The dissemination process [of self health monitoring] is sure to speed up even more now thanks to the widespread use of new communication instruments, such as smartphones. For example, these devices can be used for documentation purposes such as in an activity study, where a phone call at specific times during the day prompts a patient to complete a questionnaire the results of which are then linked to GPS data. This kind of ‘electronic diary’ can be very useful as it can have preventive or therapeutic benefits for the patient. Pharmaceutical companies also benefit as these new instruments can be used effectively in clinical trials of their products.

Substantial reductions in hospital readmissions, emergency visits, and cost of care for patients with CHF might be achieved by widespread deployment of distance technologies to provide post-hospitalization monitoring.

To restate the obvious, our smartphones now function at the level of personal computers with the advantage that they are readily accessible and can be connected to other devices that measure blood pressure, for example, or even hematocrit or blood oxygen levels. "Lab-on-a-chip" devices with a far broader test menu will be available not too far in the future. If you can process a credit card transaction with an iPhone, you can certainly use it to monitor your health status.

In my opinion, federal regulation of healthcare IT (HIT) would be a very significant barrier to innovation and progress in the field, but it may be in the cards if Congress has its way (see: Congress Pushes HHS to Regulate HIT). Here an excerpt from a recent article about this topic:

Legislation soon to be voted on in Congress and expected to pass lays the framework for federal regulation of health information technologies.The health I.T. language is part of a final version of the Prescription Drug User Fee Amendments Act of 2012, worked out in a House-Senate conference committee. Companies pay user fees, which in turn help pay for FDA regulatory programs. The bill requires the Department of Health and Human Services within 18 months of enactment to publish a report “that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety and avoids regulatory duplication.” The regulatory strategy and recommendations would be published on the Web sites of the FDA, Federal Communications Commission, and Office of the National Coordinator for Health Information Technology. The HHS Secretary could convene a working group of stakeholders to give input on the strategy and recommendations.The conference committee agreement has been placed in S. 3187, which the full House and Senate will vote on before being sent to President Obama for his signature. The bill includes several steps to combat drug shortages....The legislation also sets deadlines for establishment of unique medical device identifiers.

Part of my distaste for federal regulation of HIT is based on my experience with FDA oversight over blood bank software. Luckily, this is the only component of LIS software that is regulated in this way (see: FDA and the Regulation of Lab Software and Algorithms). As soon as this regulatory oversight was required, further development of this type of software almost came to a complete halt. Moreover, LIS vendors that might have reasonably been expected to develop a blood bank module elected not to do so. The cost of software development for the blood bank became prohibitory. A rigid regulatory environment tends to favor the largest incumbent vendors of LIS software. They have regulatory and compliance staffs and are able to pick their way more easily through the regulatory maze and pass on the added cost to their clients. This suppresses innovation in the field because often the smaller vendors are often the most innovative.

More regulation in the EMR sector will also favor large, incumbent vendors. Because they have so many employees, they can exert tremendous influence over their state congressional delegations that can lobby on behalf of the company. The net result is positive spin for these companies. In this context, I am reminded of the strong pressure from Congress that has been exerted to deinstall the VA's much admired EMR, VistA, that consists of nearly 160 integrated software modules for clinical care, financial functions, and infrastructure. Despite several decades of successful operations and a long track record of success, members of Congress, working on behalf of the companies located in their home states, have lobbied to have it ripped out and replaced by a COTS (commercial off-the-shelf software) EMR (see: VistA replacement to look at future of IT). This is not to say that VistA is perfect -- only that open-source EMR software has much to recommend it and that the federal government can be swayed by Congressional pressure.

I have blogged extensively about medical tourism in the past. A recent note in the excellent blog Marginal Revolution by economist Alex Tabarrok taught me some things that I did not know (see: Medical Tourism). I reproduce his note below in its entirety. If you pursue some of the lower cost surgery options mentioned, be sure to factor the quality of care into your decision. ---BAF

We have all heard about medical tourism to India, Singapore or Thailand, places where patients can enjoy high quality and low prices. But do you know about medical tourism to the United States? By some estimates, around 400,000 people travel to the United States for medical treatment every year and the big surprise is that for tourists U.S. health care prices can be very low! Canadians coming to the United States can get a knee replacement for less than half of what Americans pay and at a price not much more than they would pay in India. I learned this from John Goodman’s very interesting new book, Priceless: Curing the Healthcare Crisis (this is an Independent Institute book where I am director of research).

Nor is that the end of the story. Here is Goodman on an even more surprising twist:

Moreover, you do not have to be a foreigner to benefit from domestic medical tourism. Colorado-based BridgeHealth International offers US employer plans a specialty network with flat fees for surgeries paid in advance that are 15 percent to 50 percent less than a typical network. North American Surgery, Inc., has negotiated deep discounts ["for the uninsured, under-insured, and self-insured"] with 22 surgery centers, hospitals and clinics across the United States as an alternative to foreign travel for low-cost surgeries. As noted, the “cash” price for a hip replacement in the network is $16,000 to $19,000, making it competitive with facilities in India and Singapore.

One reason why so little is known about the domestic medical tourism market is that hospitals prefer that most of their patients not know about it. The reason: they are often offering the traveling patient package prices not available to local patients. That occurs because the hospital is only competing on price for the patients who travel.

To be sure, the prices paid in the “travel” market are probably closer to marginal prices than average prices. Nevertheless, I think Goodman is absolutely right to focus in on the sectors of the health care economy which are competitive, it is in these sectors that we see listed prices, falling costs and increasing quality. Priceless is about how we can expand the competitive sectors. More on the book here.

Researchers from the University of Southern California and Brown University analyzed the 2006 Minimum Data Set (MDS) assessments of all Medicare/Medicaid patients admitted to a nursing home for the first time. Among more than 230,000 patients in nearly 10,000 nursing homes across the country, the researchers found that 21% of newly admitted nursing home residents sustained at least one fall during their first 30 days in the facility....While fall rates among long-term nursing home populations are well documented, the nationwide study is believed to be the first of its kind to specifically analyze fall rates among newly admitted nursing home residents. Because newly admitted nursing home residents are in a novel environment and are unfamiliar to staff, identification and management of fall risk poses a particular challenge.“A fall can delay or permanently prevent the patient from returning to the community, and identifying risk of falling is essential for implementing fall prevention strategies and facilitating successful discharge back to the community.”

The CDC has reported that approximately 1,800 nursing home residents die each year as a result of a slip and fall accident. Thousands more suffer serious and disabling injuries as a result of a slip and fall accident. The CDC report finds that the most common causes of nursing home falls are:

Muscle weakness and walking or gait problems account for about 24% of the falls in nursing homes.

Medications can increase the risk of falls and fall-related injuries. Drugs that affect the central nervous system, such as sedatives and anti-anxiety drugs, are of particular concern.

Other causes of falls include difficulty in moving from one place to another (for example, from the bed to a chair), poor foot care, poorly fitting shoes, and improper or incorrect use of walking aids.

The mention of fall prevention strategies in the first quote caught my eye. It's clearly impossible in most nursing home settings to have attendants providing constant surveillance for residence. As noted above, patients newly admitted to a nursing home are encountering a novel environment and the risk of falls is much higher. The multifactorial causes for nursing home falls suggest that no one solution to this problem will suffice.

The newly low cost of Plavix, one of the biggest-selling drugs, is intensifying debate among cardiologists over how to make sure patients get optimal benefit from any blood-thinning medication.A generic version of Plavix became available this month so there is an incentive to switch patients to it.But, nearly a third of patients prescribed a blood thinner to prevent heart attack or stroke have a genetic variation that limits their response to Plavix. For these patients, some doctors prescribe Effient or Brilinta, two rival drugs used by far fewer patients. Although these cost more than the generic version of Plavix, they don't appear to be affected by the genetic variation. Some researchers also are studying whether increasing the dose of Plavix can overcome the genetic limitation....Tests are available to assess a patient's responsiveness to Plavix. But factors besides genetics, such as diabetes, can affect the drug's performance. And so far no study has shown that identifying poor responders and switching them to alternative therapies reduces their risk....Absent more definitive evidence, health plans are expected to steer patients away from more expensive strategies in favor of generic Plavix.

"We have switching programs to help get patients to the lowest cost agent," says Steve Miller, chief medical officer of Express Scripts Inc., which manages prescriptions for 90 million Americans....More than 50 million Americans with cardiovascular disease have taken the drug since it was approved in the U.S. in 1997....Doctors expect the generic version of Plavix, called clopidogrel, will initially cost about $1 a day. That compares with the wholesale cost of $6.44 a day for brand-name Plavix and similar prices for Eli Lilly & Co.'s Effient, at $6.38 a day, and AstraZeneca PLC's Brilinta, which lists for $7.68 per day. Doctors hope the lower price for generic Plavix will encourage more patients to stay on the medicine once they start taking it....

At Brigham and Women's Hospital, in Boston, doctors are making Brilinta their preferred drug, says cardiologist Christopher Cannon. But his colleague Jessica Mega led a recent study that found tripling the dose of clopidogrel adequately blocked clotting of platelets for most patients resistant to the standard dose. Whether that translates into reduced risk of heart attacks hasn't yet been shown.Dr. [Eric] Topol and his colleagues at Scripps and doctors at Vanderbilt University offer patients genetic testing to help guide decisions on anti-platelet therapy. They also are studying whether the strategy improves care for those resistant to Plavix.

There is no question that Plavix has been a blockbuster ""blood-thinning" agent over the years. Because of its familiarity among physicians, I suspect that there would be a tendency for them to favor the Plavix generic now coming to market. However and as noted above, "nearly a third of patients prescribed a blood thinner to prevent heart attack or stroke have a genetic variation that limits their response to Plavix." Understandably, there are studies underway to determine whether tripling of the dose of clopidogrel adequately blocks platelet clotting AND reduces the incidence of future heart attacks.

Here's a quote from the deCODEhealth web site, one of the companies that offers the relevant genetic testing prior to the selection of the most appropriate drug to administer:

Analyzes five SNPs in the SNP gene that affect response to the anti-platelet drug clopidogrel. This test identifies those who may need adjustment of their clopidogrel dose or who should be put on an alternative medication to prevent recurrent adverse cardiovascular events.

To restate the obvious, the cost of the genetic testing would need to get factored into the savings realized by the use of the generic equivalent but this would be a one-time cost compared to the savings of using the generic over a lifetime. The cost differences between the generic clopidogrel and Effient and Brilinta, as noted above, are very significant.

Veiled or overt hostility in a hospital setting, particularly nurse-nurse and nurse-physician, may strike a familiar note for many healthcare professionals. However, the following article marks the first time I have seen it described so vividly and in such detail (see: Hostility in healthcare):

A nurse rolls her eyes when you ask her for help....A circulator doesn’t tell the scrub nurse that the instrument the surgeon selected has fallen on the floor. Are these behaviors common in nursing, or part of a nurse’s rite of passage? Or are they something more insidious – horizontal hostility?....A significant body of research suggests these behaviors are prevalent and destructive to the team, yet hidden from view. While roughly 10 per cent of all professions report disruptive behaviors, the number is higher in healthcare – about 30 per cent....

Why would these behaviors happen more frequently in healthcare than the general workforce? Because they are directly linked with stress and the medical field abounds with high stressors, both internal and external: increased acuity of patients, decreased length of stay in hospital, more chronic and complex illnesses, not enough resources, sick time and the emotional work of nursing. And the second major cause is [lack of] power: when any group of people has been without the power to improve or change their situation over many decades, they unconsciously lash out at each other. We know so much about our patients, yet so little about how we ourselves function as social animals in groups....

Significant research exists to confirm the damage caused by relationship conflict in healthcare; particularly aggression, verbal abuse, and horizontal hostility. Relationship conflict affects morale, satisfaction, patient safety, and quality of care. Nurses who report the highest degree of conflict also experience the highest degree of burnout....This data is no surprise to managers who spend 30-40 per cent of their workday dealing with some form of workplace conflict.... Because resolving the quarrels that result from poor relationships can be exhausting and time consuming, many managers tend to ignore nurse-to-nurse conflict, or act like a third party and negotiate compromise in order to end an energy-draining situation quickly. But neither of these strategies is effective, and the responsibility for creating a professional work environment ultimately lies with each individual nurse. If you see it, you own it.

I was discussing nurse hostility toward house officers with one of the latter recently. She offered the following advice: "You do not want to get on the wrong side of hospital nurses or you are dead." And how does one get on the wrong side of nurses, I asked, pretty much knowing the answer. There are a number of ways, she said, but one of the most common is not treat them with proper respect and in a dismissive manner.

Teaching hospitals are pressure cookers with high-acuity patients and with much of the care rendered by physicians-in-training who may not always understand some of the unwritten rules. The causitive factors underlying hostile behavior on the part of nurses are clear and stated clearly in the excerpt above -- high stressors and a relative lack of power on the part of the nurses. I don't know to what extent the topic of "eye rolling" is discussed during house officer or nurse training. However, I am sure of one thing. It needs to be dealt with. As noted above, "if you see it, you own it." I am also sure about one other thing. As stressful as these hostility problems can be for the physicians and nurses involved, the patients have the most at stake and are the ones who are put most at risk by these behaviors.

In my blog note of two days ago, I began to present my personal interpretation of some of the significant ideas that surfaced during the recent API Strategic Summit (see: Lessons from the API Strategic Summit: Beaker LIS Is Not "Free"). The conference was convened to discuss the future of the LIS and pathology informatics in the era of powerful EMRs. For today's note, I would like to discuss the concept of the "pathology/LIS layer" as presented by John Gilbertson, representing the Harvard pathology department and Massachusetts General Hospital, part of Partners HealthCare.

In his lecture, John defined the pathology/LIS layer in the following way: a common LIS as a foundation for clinical collaboration between the [various clinical] departments [within Partners HealthCare]. He went on to say that the pathology/LIS layer was the key tool for executing an "enterprise pathology service." He then listed the following reasons why the departments of pathology were able to negotiate the deployment of this pathology/LIS layer with health system executives:

There is a functionality gap

The healthcare system must understand that pathology is foundational, unique, complex, and valuable

Know what you want...and have a plan

Pathology has to speak and with one voice

A strong, trusted vendor in place

Have a vision [for] the future

Unfettered access to data

As I understand this approach, all of the Partners hospitals will use a common LIS to deliver pathology services to each hospital in the health system. The hospitals will collaborate on IT projects such as this one relating to pathology. As a preface to his lecture, John announced that MGH has a ten-year-agreement with Sunquest to help co-develop aspects of the Sunquest AP-LIS. For me, the most important idea underlying this idea of a "pathology/LIS layer" is that the pathology departments within his health system were able to "speak with one voice" and lobby the executives for the deployment of a common, highly functional LIS to be used collaboratively across multiple hospitals.

In my note yesterday, I began my personal interpretation of some of the most significant ideas that were discussed during the recent API Strategic Summit (see: Lessons from the API Strategic Summit: Beaker LIS Is Not "Free"). The conference was convened to discuss the future of the LIS and pathology informatics in the era of powerful EMRs. For today's note, I would like to discuss the term best-of-breed LIS. This topic was prompted by a question posed to me at the Strategic Summit by the president of the API, Ray Aller. He asked: why is is only now that we are beginning to grapple with a formal defintion for a best-of-breed (BOB) LIS? The answer is that for approximately four decades, there was no need to define a BOB LIS because everyone thought that they understood the term. In other words, there was a general consensus about the definition. This consensus now seems to be growing weaker.

Simply put, a BOB LIS is a system supplied by a single vendor with a broad range of modules and functionalities, each of which was deemed to be superior, or at least equal, to the competing systems in the market. It was also commonly understood that the LIS market was segmented by hospital/lab size so the return-on-investment (ROI) needed to be factored into this equation. An LIS designed for a large, complex lab might deliver too big and expensive a "payload" for a smaller lab so a different LIS might be considered BOB for that smaller lab segment.

It was axiomatic in the LIS world that the founders of LIS companies had emerged from the clinical lab industry or that the LIS vendors would always hire lab professionals to help design their software and serve as liaisons to lab clients. It was also axiomatic that there was an active "conveyor belt" for ideas about new lab functions between the hospital lab professionals and the LIS vendors. The goal was to continually enhance the LIS software as the overarching lab mission evolved and changed.

The definition for a BOB began to unravel when some vendors began to focus on the requirements of individual labs/functions such as blood bank, surgical pathology, or lab outreach. Some of these specialized vendors began to outshine the "classic LIS vendors" at their own game. In other words, they developed expertise in smaller and more specialized lab niches. An example today is whole-slide-imaging for which specialized vendors provide both hardware (i.e, slide scanners) and the requisite support software. Lab professionals responded by retaining their "classic LIS" but also purchasing these new systems and interfaced them to their classic LISs.

A new, competing model is now rapidly coming to the forefront -- the enterprise-wide-solution (EWS) such as that provided by Epic. Epic views the electronic medical record (EMR), the major software tool used by clinicians, as the epicenter of the hospital computing universe and the functionality requirements of diagnostic departments as subservient. In this Epic model, the company conceptually supplies "shrink-wrap" integration of all modules so that hospital CIO's don't have to deal with the previous "Tower of Babel." An EWS vendor like Epic need not strive to develop a BOB LIS. Beaker only needs to be "good enough" because of the overall appeal of the value proposition of the Epic EMR to CIOs. In response, the hospital lab leadership needs to patch the lab functionality gaps opened by Beaker by deploying "specialized" lab systems or retain their BOB LISs. This is optimistically viewed as a stopgap measure until Epic delivers all the required software solutions.

We have just completed the API Strategic Summit, a gathering of pathology informaticians and lab professionals from across the country in Pittsburgh underwritten by Cerner, Sunquest, McKesson, and SCC Soft (see: Attend the Strategic Summit: Help Decide the Future of the LIS and Pathology Informatics). The conference consisted of a total of 12 lectures over an evening and a day. Its focus was an analysis of the future of the LIS and pathology informatics in the era of dominant EMRs. More detailed strategic questions that were addressed at the conference are available on the API web site.

The first lecture on the evening of June 7, 2012, was by Mike Becich who discussed the future of pathology and personalized medicine. The next day's schedule consisted of a total of 11 lectures, four by representatives of the corporate underwriters and seven others by faculty members selected on a competitive basis. A white paper is now under development that will provide a formal summary of the entire event. Meanwhile, I want to present, in a series of blog notes on Lab Soft News, what I personally consider the major take-away lessons from the conference.

Epic is rapidly becoming the most common EMR to in hospitals 500 beds or larger and grabbing most new contracts and installs. The company offers an LIS called Beaker as one of its modules as part of its business model of providing an "enterprise wide solution" (EWS). One commonly hears on the street that Beaker is free. This assertion requires significant qualification. If lab professionals accept this idea at face value, their future careers clould be in serious jeopardy. Beaker is "free" only in the sense that its software licensing fee is wrapped up in up-front price paid for the Epic EWS by hospitals. However and more importantly, there are significant installation costs involved in bringing Beaker live. Two LIS consultants present at the Strategic Summit estimated the current installation costs for Beaker at about $800,000 to $1,400,000, depending on hospital size. These are only estimates and may vary by deal and individual negotiations. By way of contrast, a fully-functional, best-of-breed LIS for a medium-sized hospital would cost roughly $2,000,000 for licensing fees and installation. However, the functionality of Beaker is significantly limited.

I was also told by faculty and attendees at the Strategic Summit that Beaker provides good functionality for chemistry and hematology and average or sub-average functionality for microbiology and surgical pathology. There are no blood bank or molecular pathology modules at this time or a lab-oriented outreach product (see: Details about Epic's Beaker LIS, Supplied by the Company). Lab rules capability is limited to what is offered by the Data Innovations "middleware" that is baked into Beaker with most of the rules focused on chemistry and hematology. Beaker plus the additional software that must be installed to achieve the necessary lab functionality may well end up costing the same or more than a best-of-breed system that begins with broad functionality. In addition and with the "Beaker plus" (i.e., hybrid) design approach, the lab is faced with a major system integration headache.

Given these circumstances, the question needs to be asked why would the lab leadership choose to install the immature Beaker product at all. From my perspective, there are two possible reasons. The first is to satisfy their hospital executives who may be laboring under the misapprehension that Beaker is free and also eager to please Epic with another Beaker install. The second reason is to provide lab professionals working in the hospital the "opportunity" to teach the Epic personnnel how to manage lab workflow and lab computing. As presented in a previous note posted in August 2011, the company reported that it had assigned about 50 employees out of more than 4,000 to LIS development, installation, and support (see: Here Comes Epic's Beaker LIS -- Ready or Not). This number may be larger now. I was told at the Strategic Summit that the company has almost no "lab experts" on the payroll as most of us would define the term. The commpany is going to need a lot of help to turn Beaker into a mature, best-of-breed LIS.